Lilly Alzheimer's Drug Phase 2 clinically obtained positive data

It is understood that the above-mentioned Phase 2 clinical trial called RAILBLAZER-ALZ (NCT03367403), is a randomized, placebo-controlled, double-blind, multi-center clinical study, a total of 272 patients, designed to assess the safety, tolerance and efficacy of donanemab treatment of early symptomatic Alzheimer's disease.
final clinical study data showed that donanemab reached the main endpoint of the study, which resulted in a statistically significant 32 percent drop in iADRS from baseline to 76 weeks compared to placebo.
iADRS combines cognitive measurements with ADAS-Cog13 and functional measurements of ADCS-iADL, two common measurement methods for Alzheimer's disease.
compared to placebos, donanemab also showed consistent improvement in measuring all pre-specified secondary endpoints for cognition and function, but did not achieve nominal statistical significance at each secondary endpoint.
, imaging tests of amyloid deposition showed a significant reduction in amyloid plaques in the brains of patients treated with donanemab.
the average level of amyloid plaques in a patient's brain dropped by 84 units, according to a scale used to assess amyloid levels called Centiloid.
their baseline level was 108, while a scan of less than 25 was considered negative, similar to that of healthy people.
note that the trial is a Phase 2 clinical trial, and the final efficacy of donanemab has yet to be tested in a larger Phase 3 clinical trial.
, but all in all, the industry believes that, to some extent, the positive data for Donanemab II offer at least hope for the ongoing development of Alzheimer's drugs.
According to the 2018 World Alzheimer's Report, released by the International Alzheimer's Association, there are 50 million people living with Alzheimer's disease worldwide by 2018, with social-related costs of $1 trillion, and with an ageing population, 82 million people are expected to have Alzheimer's worldwide by 2030 and 152 million by 2050.
's large sick population has attracted competition from drug companies, which have invested more than $250 billion in drug research and development in that direction since 2002, but only six products have been approved by the FDA in history, and none of these drugs have been treated for the disease, and none of them have been able to stop or delay the progression of AD.
November 2, 2019, the first original Chinese and the world's first sugar multi-target anti-Alzheimer's innovative drug Phase 9 was approved by the National Drug Administration for mild to moderate Alzheimer's disease to improve patient cognitive function, the product's listing filled the gap in the field of 17 years of no new drugs on the market, causing unprecedented concern in the industry.
, Phase 9 has been approved by the FDA for an international Phase III. clinical trial, which is expected to be completed in 2024 and new drug applications will begin in 2025.
The discovery of the underlying mechanisms of AD and the search for drugs that can prevent pathogenic steps that cause neuron damage is a very long and costly process, and it is not entirely clear what causes and specific mechanisms of AD, and current drug development is based on various hypothesis theories, including amyloid hypothesis", nerve fiber entanglement, neuroinstation, brain trauma, and so on.
Among them, the "amyloid protein hypothesis" is the mainstream of Alzheimer's-related drug research and development in recent years, the main content of the hypothesis is that the pathogenesis of Alzheimer's patients can be summarized as abnormal deposition of amyloid protein (A beta) in the brain led to brain damage and loss of consciousness in Alzheimer's patients, while abnormal accumulation of amyloid protein can also lead to the degradation of the protein problems.
the most well-known clinical research drug based on the "amyloid protein hypothesis" at this stage is aducanumab, a drug that has under experienced a major reversal of fortunes.
it was terminated because there was no improvement in mild cognitive impairment caused by Alzheimer's disease and mild Alzheimer's disease in two Phase III clinical studies, and it was likely that it would be difficult to reach the end of the main efficacy, and then because of clinical results New findings with positive data have re-launched the listing application, and in August 2020, the FDA accepted and granted priority review of Alzheimer's disease's biopharmaceutical license for the new drug Aducanumab.
the Prescription Drug User Payment Act (PDUFA), the FDA's review target date is March 7, 2021.
FDA said it would take early action to expedite approval of the application, if conditions permit.
At the same time, the European Medicines Agency (EMA) has accepted aducanumab's Application for Market Authorization (MAA), which, if approved, would be the first therapy to reduce the clinical decline of Alzheimer's disease and the first to demonstrate that removing A-beta protein could lead to better clinical outcomes.